Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: CAR-T Cell Therapy; Extracellular Vesicles

Treatments: Other: Patients who are candidates for CAR-T cell therapy for hematologic malignancy

Study type: Observational

Funder types: Other

Identifiers

NCT06554951

CARE_24

Details and patient eligibility

About

Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested.

Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients affeccted by any hematological malignancies (r/r B cell lymphoma, B cell acute leukemia and multiple myeloma) undergoing (or whit indication to) CAR-T cell infusion with a CAR-T cell product;
• age: 18 years or greater;
• obtained written consent to the study participation.

Exclusion criteria

• none